BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1022664 · Received April 1, 2008

    Report

    Report Number
    1823260-2008-02897
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 330MG/DL, 227MG/DL, 522MG/DL, AND 217MG/DL ON THE ADVANTAGE SYS WITHIN 10 MINS. NO TREATMENT INFO PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYS AND REPLACED WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550057

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HUMULIN - 1 MONTH SLIDING SCALE| LANTUS <1 MONTH